Trial Outcomes & Findings for Physical Activity and Leisure-time Study (PALS) (NCT NCT01342471)
NCT ID: NCT01342471
Last Updated: 2012-11-09
Results Overview
Change in pedometer measured steps per day between 0 and 6 months
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
58 participants
Primary outcome timeframe
0 and 6 months
Results posted on
2012-11-09
Participant Flow
recruited by flyers and newspaper advertisements, were enrolled in a university-based PA program during the months of September through November, 2010.
Participant milestones
| Measure |
30-min Walk
Instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
TV Commercial Stepping
Instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (\~9 or 10), short (\~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical Activity and Leisure-time Study (PALS)
Baseline characteristics by cohort
| Measure |
30-min Walk
n=29 Participants
Instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
TV Commercial Stepping
n=29 Participants
Instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (\~9 or 10), short (\~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
50.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 and 6 monthsChange in pedometer measured steps per day between 0 and 6 months
Outcome measures
| Measure |
30-min Walk
n=29 Participants
Instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
TV Commercial Stepping
n=29 Participants
Instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (\~9 or 10), short (\~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
|---|---|---|
|
Physical Activity (Steps/Day)
|
2956 steps/day
Standard Deviation 604
|
2994 steps/day
Standard Deviation 918
|
SECONDARY outcome
Timeframe: 0 and 6 monthsChange in total energy intake(kcals/day) between 0 and 6 months
Outcome measures
| Measure |
30-min Walk
n=29 Participants
Instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
TV Commercial Stepping
n=29 Participants
Instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (\~9 or 10), short (\~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
|---|---|---|
|
Total Energy Intake
|
-354.2 kcals/day
Standard Deviation 63.5
|
-347.9 kcals/day
Standard Deviation 256
|
SECONDARY outcome
Timeframe: 0 and 6 monthsChange in energy intake (kcals/day) while watching TV between 0 and 6 months
Outcome measures
| Measure |
30-min Walk
n=29 Participants
Instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
TV Commercial Stepping
n=29 Participants
Instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (\~9 or 10), short (\~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
|---|---|---|
|
TV Related Energy Intake
|
-516.6 kcals/day
Standard Deviation 176.4
|
-282.6 kcals/day
Standard Deviation 69.7
|
SECONDARY outcome
Timeframe: 0 and 6 monthsChange in weight in kgs between 0 and 6 months
Outcome measures
| Measure |
30-min Walk
n=29 Participants
Instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
TV Commercial Stepping
n=29 Participants
Instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (\~9 or 10), short (\~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
|---|---|---|
|
Weight
|
-0.4 kg
Standard Deviation 0
|
-0.7 kg
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 0 and 6 monthsChange in self-reported TV viewing time per day between 0 and 6 months
Outcome measures
| Measure |
30-min Walk
n=29 Participants
Instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.
30-min walk : Participants were instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
TV Commercial Stepping
n=29 Participants
Instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (\~9 or 10), short (\~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.
TV commercial stepping : Participants were instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
|
|---|---|---|
|
TV Viewing Time
|
-1.4 hr/day
Standard Deviation 0.6
|
-1.2 hr/day
Standard Deviation 0
|
Adverse Events
30-min Walk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TV Commercial Stepping
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place